A Randomized, Double-blind, Comparison of the Efficacy and Safety of Amisulpride Versus Low-dose Amisulpride Plus Low-dose Sulpiride in the Treatment of Schizophrenia
NCT ID: NCT01615185
Last Updated: 2016-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
96 participants
INTERVENTIONAL
2008-01-31
2011-12-31
Brief Summary
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Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d).The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost.
Detailed Description
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Method: In this 6-week, double-blind, fixed-dose study, patients with schizophrenia (DSM-IV diagnosis) are randomly assigned to amisulpride (800 mg/d) or amisulpride (400 mg/d) plus sulpiride (800 mg/d). The hypothesis is that the two treatment groups have the similar efficacy and safety, but different cost. The efficacy assessment was the change from baseline in the score on the Clinical Global Impression-Severity (CGI-S), Positive and Negative Syndrome Scale (PANSS) and subscales (positive scale, negative scale, general psychopathology scale), Calgary Depression Scale for Schizophrenia (CDSS), and Global Assessment of Functioning (GAF). Safety assessments include the change from baseline on Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Scale (BAS), and UKU Side-effects Rating Scale (UKU), and the change from baseline in prolactin levels, body weight, vital sign, blood pressure, AC glucose level, and lipid profiles(cholesterol, high density lipid protein \[HDL\], low density lipid protein \[LDL\], and triglyceride \[TG\]).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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sulpiride plus amisulpride
sulpiride 800mg/d + amisulpride 400mg/d
full-dose amisulpride
amisulpride 800mg/d
full-dose amisulpride
amisulpride 800mg/d
full-dose amisulpride
amisulpride 800mg/d
Interventions
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full-dose amisulpride
amisulpride 800mg/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CGI \>=4
* washout of antipsychotics at least 3-5 days
* written informed consents
Exclusion Criteria
* History of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics
* treatment-resistant schizophrenia
* long-acting antipsychotics in the past 3 months
* comorbid with substance abuse/dependence
* female subjects with pregnancy
* severe physical illness
18 Years
55 Years
ALL
No
Sponsors
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Kaohsiung Kai-Suan Psychiatric Hospital
OTHER_GOV
Responsible Party
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Ching-Hua Lin, MD, PhD
Chief of Adult Psychiatry
Principal Investigators
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Ching-Hua Lin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kai-Suan Psychiatric Hospital
Locations
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Kai-Suan Psychiatric Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Leucht S, Wahlbeck K, Hamann J, Kissling W. New generation antipsychotics versus low-potency conventional antipsychotics: a systematic review and meta-analysis. Lancet. 2003 May 10;361(9369):1581-9. doi: 10.1016/S0140-6736(03)13306-5.
Kapur S, Seeman P. Does fast dissociation from the dopamine d(2) receptor explain the action of atypical antipsychotics?: A new hypothesis. Am J Psychiatry. 2001 Mar;158(3):360-9. doi: 10.1176/appi.ajp.158.3.360.
McKeage K, Plosker GL. Amisulpride: a review of its use in the management of schizophrenia. CNS Drugs. 2004;18(13):933-56. doi: 10.2165/00023210-200418130-00007.
Chakos MH, Glick ID, Miller AL, Hamner MB, Miller DD, Patel JK, Tapp A, Keefe RS, Rosenheck RA. Baseline use of concomitant psychotropic medications to treat schizophrenia in the CATIE trial. Psychiatr Serv. 2006 Aug;57(8):1094-101. doi: 10.1176/ps.2006.57.8.1094.
Lin CH, Wang FC, Lin SC, Huang YH, Chen CC, Lane HY. Antipsychotic combination using low-dose antipsychotics is as efficacious and safe as, but cheaper, than optimal-dose monotherapy in the treatment of schizophrenia: a randomized, double-blind study. Int Clin Psychopharmacol. 2013 Sep;28(5):267-74. doi: 10.1097/YIC.0b013e3283633a83.
Other Identifiers
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KSPH-2008-13
Identifier Type: -
Identifier Source: secondary_id
KSPH-2008-13
Identifier Type: -
Identifier Source: org_study_id